Prevalence, Incidence Rate, and Risk Factors of Medication-Related Osteonecrosis of the Jaw in Patients With Osteoporosis and Cancer: A Nationwide Population-Based Study in Japan.

PURPOSE: Medication-related osteonecrosis of the jaw (MRONJ) is a rare but severe adverse event of antiresorptive agents. However, the precise prevalence and factors associated with the development of MRONJ remain unknown. The present study was performed to describe the prevalence, incidence rate, and risk factors of developing MRONJ.

METHODS

We conducted a population-based retrospective cohort study using the National Database of Health Insurance, an administrative claims database of all patients in Japan. We identified patients who newly began using antiresorptive drugs from April 2015 to December 2018. The primary outcome was the development of MRONJ. We calculated the prevalence and incidence rate of MRONJ and performed a time-dependent Cox proportional hazard regression analysis to examine risk factors for developing MRONJ.

RESULTS

We identified 2,819,310 patients who newly used antiresorptive drugs during the study period. Of these patients, 2,664,104 (94.5%) had osteoporosis and 155,206 had cancer. Among the patients with osteoporosis, 1,603 (0.06%) developed MRONJ; the incidence rate was 22.9 per 100,000 person-years. Among the patients with cancer, 2,274 (1.47%) developed MRONJ; the incidence rate was 1,231.7 per 100,000 person-years. The occurrence of MRONJ was associated with poor oral conditions (including tooth extraction), age, male sex, drug type, concomitant drug use, comorbidities, cancer type, and geographic location.

CONCLUSIONS

The overall prevalence and incidence rate were low, but they were still higher than those in previous studies. Poor oral conditions were more closely related to the development of MRONJ than other factors. These findings suggest that improving poor oral hygiene may be essential to prevent MRONJ.